Proclaim™ 7 EliteRecalls & reported problems

St. Jude Medical, Inc. · Implantable Pulse Generator · Class 3 · Implant

All models of Proclaim (12)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This St. Jude Medical Proclaim Elite spinal cord stimulator is implanted for pain relief. Reports mostly describe pain at the device site, sudden shutdowns, failed communication with external devices, and inadequate pain relief. There are 7,289 reports, including 12 deaths and 5,828 injuries. One open recall, begun in May 2024, says battery replacement warnings may come less time before end of service than labeled.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 7,299
Deaths reported: 12
Injuries reported: 5,837
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 7,299 adverse event reports that list this exact device (DI 05415067020222), received between Aug 15, 2016 and Sep 29, 2026 — classified as 12 deaths, 5,837 injuries, 1,450 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (1,325 reports).

1 FDA recall record name this device's identifier, 1 still open.

14 other recalls cover devices cleared under the same FDA submission (P010032); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

May 16, 2024Open, Classified
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
Z-2368-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1,999
Wireless Communication Problem1,325
Battery Problem1,098
Premature Elective Replacement Indicator1,055
Insufficient Device Problem Information825
Application Program Freezes or Fails to Launch291
Therapeutic or Diagnostic Output Failure273
No Device Output168

Patient problems

Inadequate Pain Relief3,614
No Consequences Or Impact To Patient1,051
Failure of Implant822
Implant Pain599
Pain471
No Clinical Signs, Symptoms or Conditions432
Discomfort353
No Known Impact Or Consequence To Patient232

Recent adverse event reports

The 25 most recent of 7,299 reports, in the reporter's own words as published by the FDA.

InjurySep 29, 2026Wireless Communication Problem
Patient problems: Inadequate Pain Relief
MAUDE report 50938912 ↗
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that following recent weight loss, the patient experienced pain at the IPG site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was replaced to address the issue. Therapy was restored post-operatively.
Patient problems: Implant Pain
MAUDE report 50937454 ↗
InjurySep 29, 2026Insufficient Device Problem Information
It was reported that the patient had their system explanted for an unknown reason 3 years ago. No further information is available.
Patient problems: Insufficient Information
MAUDE report 50936954 ↗
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported the patient experienced pain at the IPG pocket site and ineffective stimulation. Surgical intervention took place wherein the patient¿s system was explanted to address the issue. NOTE: It is unknown which lead is related to this issue.
Patient problems: Implant Pain
MAUDE report 50934574 ↗
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Implant Pain
MAUDE report 50925157 ↗
InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced pain at the IPG site. As a result, surgical intervention was undertaken on 31AUG2026 wherein the IPG was replaced to address the issue.
Patient problems: Implant Pain
MAUDE report 50900729 ↗
InjurySep 22, 2026Insufficient Device Problem Information
It was reported that patient experienced an infection at an unknown site. As a result, surgical intervention was undertaken in (b)(6) 2023 wherein the leads and anchors were explanted to address the issue. Additionally, the IPG was explanted in (b)(6) 2024 for an unknown reason.
Patient problems: Insufficient Information
MAUDE report 50859437 ↗
InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50848195 ↗
InjurySep 16, 2026Wireless Communication Problem
It was reported that following an unrelated surgical procedure wherein the device was not placed into surgery mode, the IPG became unable to communicate with external devices. Troubleshooting has been unable to resolve the issue. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was replaced to address the issue. Therapy was restored post-operatively.
Patient problems: Inadequate Pain Relief
MAUDE report 50794833 ↗
InjurySep 16, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50794585 ↗
InjurySep 16, 2026Wireless Communication Problem
It was reported that following an unrelated surgical procedure wherein the device was placed into surgery mode, the IPG became unable to communicate with external devices. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein IPG was explanted and replaced to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50790228 ↗
InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient is experiencing inadequate coverage/therapy. Additionally, patient is experiencing pain at the IPG site following weight loss. As such, surgical intervention may take place at later date to address the issue.
Patient problems: Implant Pain
MAUDE report 50756961 ↗
MalfunctionSep 2, 2026Premature Elective Replacement Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573006 ↗
InjuryAug 25, 2026Insufficient Device Problem Information
It was reported that the patient had their system explanted on an unknown date for an unknown reason. Additionally, a portion of the patient's lead remains implanted. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50422523 ↗
InjuryAug 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported the patient experienced pain at the IPG site. As a result, surgical intervention was undertaken wherein the IPG was explanted, replaced and relocated to address the issue.
Patient problems: Implant Pain
MAUDE report 50394278 ↗
InjuryAug 18, 2026Wireless Communication Problem
It was reported that following an unrelated surgical procedure wherein the device was not placed into surgery mode, the IPG became unable to communicate with external devices. Troubleshooting has been unable to resolve the issue. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50306100 ↗
InjuryAug 17, 2026Insufficient Device Problem Information
It was reported the patient underwent surgical intervention on an unknown date wherein the entire system was explanted for an unknown reason.
Patient problems: Insufficient Information
MAUDE report 50286764 ↗
InjuryAug 4, 2026Insufficient Device Problem Information
It was reported that the patient underwent surgical intervention on an unknown date wherein the system was explanted for an unknown reason.
Patient problems: Insufficient Information
MAUDE report 50135194 ↗
InjuryJul 31, 2026Insufficient Device Problem Information; Migration
It was reported that the patient underwent an IPG pocket revision on an unknown date for an unknown reason.
Patient problems: Implant Pain; Insufficient Information
MAUDE report 50100122 ↗
InjuryJul 30, 2026Insufficient Device Problem Information
It was reported that the patient had their system explanted on an unknown date for an unknown reason.
Patient problems: Insufficient Information
MAUDE report 50091865 ↗
InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that following recent weight loss, the patient experienced pain at the IPG site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was replaced and relocated to address the issue.
Patient problems: Implant Pain
MAUDE report 50058717 ↗
InjuryJul 28, 2026Wireless Communication Problem
It was reported that following an unrelated surgical procedure wherein the device was not placed into surgery mode, the IPG became unable to communicate with external devices. Troubleshooting has been unable to resolve the issue. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50055060 ↗
InjuryJul 27, 2026Insufficient Device Problem Information
It was reported that patients system was explanted on an unknown day in (b)(6) of 2021 for an unknown reason.
Patient problems: Insufficient Information
MAUDE report 50046863 ↗
InjuryJul 17, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE IPG WAS EXPLANTED FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25856136 ↗
InjuryJun 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 TO ADDRESS THE ISSUE WHEREIN THE IPG WAS EXPLANTED AND REPLACED.
Patient problems: Implant Pain
MAUDE report 25646166 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010032. One submission often covers many models, so check the product and lot details in each record.

Z-0458-2026 · Oct 6, 2025 · Open, Classified
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-2511-2023 · Jul 18, 2023 · Open, Classified
Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio
Z-2509-2023 · Jul 18, 2023 · Open, Classified
Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extens
Z-2507-2023 · Jul 18, 2023 · Open, Classified
Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext
Z-2506-2023 · Jul 18, 2023 · Open, Classified
Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device
Z-2508-2023 · Jul 18, 2023 · Open, Classified
Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext
Z-2510-2023 · Jul 18, 2023 · Open, Classified
Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio
Z-2505-2023 · Jul 18, 2023 · Open, Classified
Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electr
Z-2691-2017 · Jun 2, 2017 · Terminated
Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be c
Z-2692-2017 · Jun 2, 2017 · Terminated
Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be c
Z-1785-2013 · Nov 30, 2012 · Terminated
Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 reca
Z-0025-2013 · Sep 4, 2012 · Terminated
The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode
Z-1738-2013 · Jul 26, 2012 · Terminated
Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or li
Z-3091-2011 · Jun 2, 2009 · Terminated
Software version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting im

Device details

UDI-DI	`05415067020222`
Brand	Proclaim™
Model	7 Elite
Catalog no.	3662
Company	St. Jude Medical, Inc.
Product code	LGW · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Class	Class 3
FDA submission	P010032
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jan 9, 2023

Device type (GMDN): Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included) to relieve acute and/or chronic intractable pain (analgesia). The device is programmed, controlled, and charged telemetrically by external devices.

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All STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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